Pharvaris N.V. Ordinary Shares Wells Fargo 21st Annual Healthcare Conference

Yeah. Thank you. Thank you for hosting us.

Mm-hmm. Yeah. Our journey actually started 10 years ago, and four months to be exact, when we set out to develop deucrictibant. Myself and also my co-founder had been in the HAE space, came in first 23 years ago with the company that developed icatibant. We had identified or saw a huge unmet need for an oral therapy option for people living with HAE. That is our vision then, to come up with such a molecule and then that is when we started. The scientific base of the company really focuses on the deeper understanding of the bradykinin pathway and the B2 receptor. We are proud to say that we, to our knowledge, really do have the first and only orally available B2 receptor antagonist, deucrictibant.

The nice thing about that molecule is that as compared to icatibant, it has a significantly longer half-life, which makes it suitable both for prophylaxis and on-demand development. We set out to develop with that one, the same active ingredient, two products, one for on-demand and one for prophylaxis. Now 10 years later, yesterday actually, we saw we have the data for the prophylactic phase III study. Also, as you know, in December last year, we also had the phase III data for the on-demand formulation, which is currently under review by the FDA with the PDUFA date in April. With the data that we saw yesterday, we are incredibly excited to really see that vision that we had 10 years ago is coming closer to fruition and to be able to fill that unmet need in this therapeutic space.

With the data that we saw, we are up there together with the existing therapies in the longer-acting injectables, but with the benefit of an oral option. That differentiates us from that perspective. The molecule itself also has, because of the modality and also the treatment regimen, be once daily and the flexibility of being able to start the therapy, having the activity kick in very quickly. Also of course, the relatively short washout. That means that if you discontinue the treatment or if you want to transfer over to on-demand or if you want to have a medical procedure where you cannot have drugs. That gives the concept of control is really a key factor that also differentiates us in this space.

It is a high efficacy tolerability and the oral convenience and that is in our view, then provides the benefit of maximum control for somebody living with HAE condition.

I mean, the efficacy, first of all, we're also very excited to see the replication or even potentially better than the phase II data that we saw in a phase III study and in spite of also the increased footprint of the study, more size, more diverse patient population, et cetera. We were extremely pleased with that level of efficacy. If you really compare with the patient population, type 1 and type 2 of hereditary angioedema, which is what is covered by the other injectables, we're right up there with 87% attack reduction. The primary endpoint in the overall study was 83%, because we also included a few patients with normal C1.

The overall, which was included in the primary endpoint, but the comparison directly apples to apples to the type 1 and type 2 is 87% as we also presented. Maybe, Peng, if you want to add something on the placebo side of things.

Yeah, sure. Actually, from the placebo part, maybe someone viewed that the placebo, actually, if we look at the placebo arm, the attack rate is around 2.6 attack per month compared to other HAE pivotal trial. Actually, very well, within the range between 2.3 as a pivotal trial. That's further, as Marc mentioned, that confirmed that this trial conducted very well, even though I have to say that this is the first, maybe the pivotal trial, covered all the six continentals. That we do, that have patients from not only North America and Europe, as we did for phase II, we also covered the patients from Asia Pacific, Latin American countries, and also South Africa. That's why the patient advocacy group are very excited to show really we covered a high unmet medical need globally.